REACH Regulation (EC) No 1907/2006
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| REACH Regulation (EC) No 1907/2006 | |
|---|---|
| Name | REACH Regulation (EC) No 1907/2006 |
| Adopted | 2006 |
| Jurisdiction | European Union |
| Type | Regulation |
| Status | in force |
REACH Regulation (EC) No 1907/2006 is a European Union regulatory framework addressing the production and use of chemical substances, integrating market surveillance, industrial responsibility, and public health protection within the European Commission legislative architecture, the European Parliament deliberative processes, and the Council of the European Union adoption procedures. Conceived amid policy debates involving European Chemicals Agency, Organisation for Economic Co-operation and Development, United Nations Environment Programme, and stakeholders from BASF, Dow Chemical Company, Covestro, it replaced earlier directives to create a unified regime for registration, evaluation, authorisation and restriction across member states such as Germany, France, United Kingdom, Italy and Spain.
Background and Objectives
REACH arose from interactions among institutions like the European Commission, the European Parliament, the Council of the European Union, and advisory bodies including the European Chemicals Agency and the European Environment Agency, set against international instruments such as the Stockholm Convention on Persistent Organic Pollutants, the Rotterdam Convention, and the Krems Declaration-era discussions. Political context involved influential actors and events including the Bhopal disaster, lobbying by corporations like DuPont, Shell, AkzoNobel, and campaigns by NGOs such as Greenpeace, Friends of the Earth, World Wide Fund for Nature and legal challenges referencing the Treaty of Rome and the Lisbon Treaty. Objectives included improving protection of human health cited by institutions like the World Health Organization and European Agency for Safety and Health at Work, enhancing competitiveness cited by European Council reports, and promoting substitution policies reflected in debates among stakeholders including BusinessEurope, European Trade Union Confederation, and national ministries such as the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection.
Scope and Key Obligations
REACH applies to manufacturers and importers active in markets across Belgium, Netherlands, Poland, Sweden and Czech Republic, and to downstream users including companies like Siemens, Volkswagen Group, Airbus, IKEA Group and Rolls-Royce Holdings. It covers substances, mixtures and articles interacting with supply chains involving Johnson & Johnson, Procter & Gamble, Unilever, L'Oréal, and GlaxoSmithKline. Key obligations delineated in the regulation placed duties on registrants, registries and consortia modeled after practices in European Chemicals Agency, requiring data generation, joint submission mechanisms mirrored in frameworks used by European Medicines Agency, European Food Safety Authority, and coordination with customs authorities such as European Anti-Fraud Office and national inspectorates like the Health and Safety Executive.
Registration, Evaluation, Authorisation and Restriction (REACH) Processes
The registration process requires companies including Bayer, Eli Lilly and Company, Novartis, and industrial consortia to submit dossiers to the European Chemicals Agency with chemical safety reports analogous to dossiers submitted to European Medicines Agency and European Food Safety Authority. Evaluation mechanisms invoke committees like the Committee for Risk Assessment and the Committee for Socio-economic Analysis within the European Chemicals Agency, and interact with procedures from International Labour Organization standards and the United Nations Globally Harmonized System of Classification and Labelling of Chemicals. The authorisation route addresses substances of very high concern, paralleling lists and processes referenced in the Stockholm Convention on Persistent Organic Pollutants and the Minamata Convention on Mercury, while restriction measures may be proposed by member states such as Sweden and Denmark or by the European Commission and debated in the European Parliament plenary.
Roles of Stakeholders and Governance
Governance under REACH features the European Chemicals Agency as technical authority, the European Commission as policy executor, and member-state competent authorities such as Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, Federal Institute for Occupational Safety and Health, and Italian Institute of Health for enforcement. Industry associations like CEFIC, European Chemical Industry Council, European Association of Chemical Distributors and trade unions such as the Trades Union Congress participate in stakeholder consultations alongside NGOs including ClientEarth and BirdLife International. Legal oversight can involve the Court of Justice of the European Union and national courts like the Bundesverwaltungsgericht in disputes; scientific advice may come from institutions such as European Molecular Biology Laboratory, Max Planck Society, Karolinska Institutet, Imperial College London and University of Cambridge researchers.
Implementation, Compliance and Enforcement
Member states implement REACH through agencies like the Health and Safety Executive in the United Kingdom (pre-withdrawal) and the French Agency for Food, Environmental and Occupational Health & Safety in France, coordinated by the European Chemicals Agency and monitored by the European Court of Auditors. Enforcement involves customs cooperation with bodies such as Europol and national inspectorates in Spain and Portugal; compliance tools reference standards from International Organization for Standardization, European Committee for Standardization, and testing guidance akin to that adopted by OECD. Dispute resolution and sanctions have been adjudicated in forums including the Court of Justice of the European Union and national tribunals like the Conseil d'État and Bundesverfassungsgericht.
Impact, Criticism and Revisions
REACH has influenced corporate strategies at firms such as 3M, Ford Motor Company, BMW, Henkel, and Siemens Energy and prompted academic analyses at institutions like London School of Economics, University of Oxford, Harvard University, and Yale University. Critics include trade bodies such as American Chemistry Council and commentators in media outlets like Financial Times, The Economist, Le Monde, and The New York Times highlighting costs to small enterprises represented by European Small Business Alliance and regulatory burdens debated in meetings of the European Council. Revisions and adaptations have been proposed in line with European Green Deal initiatives from the European Commission and reviewed in reports by the European Environmental Agency and the European Court of Auditors, with periodic amendments influenced by international agreements like the Basel Convention and scientific assessments from European Centre for Disease Prevention and Control.